Nurses' spontaneous reporting of adverse drug reactions: expert review of routine reports

J Nurs Manag. 2014 Apr;22(3):322-30. doi: 10.1111/jonm.12003. Epub 2012 Nov 2.

Abstract

Aim: The aims of this study were to analyse spontaneously reported adverse drug reactions according to their previous description, seriousness, causality and the reporting professional.

Background: Previous findings showed that fewer nurses than physicians and pharmacists report adverse drug reactions. This is not attributed to any lack of ability in identifying adverse drug reactions.

Method: Adverse drug reactions received by the Central Portugal Regional Pharmacovigilance Unit, between 2001 and 2011, were studied. Certain and probable adverse drug reactions were included to test differences between professional groups for serious and non-serious adverse drug reactions.

Results: The Central Portugal Regional Pharmacovigilance Unit received 1014 adverse drug reactions. Fifty-four nurses reported 66 adverse drug reactions, whereas 232 physicians and 145 pharmacists reported 589 and 357 adverse drug reactions, respectively. Considering the number of practising professionals, it was estimated that 0.55% of nurses, 3.96% of physicians and 7.08% of pharmacists have reported an adverse drug reaction. Of the 633 adverse drug reactions assessed as certain or probable, 46 (21 serious), 387 (192 serious) and 198 (77 serious) were reported from nurses, physicians and pharmacists, respectively. There were no differences in the reporting of serious adverse drug reactions among nurses, physicians and pharmacists.

Conclusions: Nurses are able to identify serious adverse drug reactions although they report less than other professionals.

Implications for nursing management: Nurses need to increase their involvement in spontaneous reporting schemes by taking responsibility for routinely reporting suspected adverse drug reactions.

Keywords: adverse drug reaction; nurses; pharmacovigilance; seriousness; spontaneous reporting.

MeSH terms

  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Nurses / psychology
  • Nurses / standards*
  • Pharmacovigilance
  • Portugal
  • Risk Management / statistics & numerical data*
  • Self Efficacy